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NCT05630768 Clinical Trial

Efficacy and Safety of Actonel® After Denosumab Discontinuation in Postmenopausal Osteoporosis Women

Postmenopausal Osteoporosis Clinical Trial

Official title:
A Multicenter, Open-label, Single-arm Clinical Trial to Evaluate the Efficacy and Safety of Actonel® After Denosumab Discontinuation in Postmenopausal Osteoporosis Women

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT05630768
Other study ID # ATN_PMO_IV
Secondary ID
Status Recruiting
Phase Phase 4
First received
Last updated
Start date January 3, 2023
Est. completion date February 2025

Study information
Verified date December 2023
Source Dong-A ST Co., Ltd.
Contact Yumie Rhee
Phone +82-2-2228-1973
Email yumie@yuhs.ac
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

To evaluate the effect of 1 year of risedronate treatment on the prevention of bone loss after denosumab discontinuation in denosumab-treated post-menopausal osteoporosis for a year

Recruitment information / eligibility
Status Recruiting
Enrollment 155
Est. completion date February 2025
Est. primary completion date February 2025
Accepts healthy volunteers No
Gender Female
Age group 50 Years to 80 Years
Eligibility Main Inclusion Criteria: 1. Postmenopausal women 2. Patients diagnosed with postmenopausal osteoporosis and administered denosumab for 1 year Main Exclusion Criteria: 1. Any contraindication to risedronate 2. Those evaluated as inappropriate at the discretion of the investigator

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Risedronate Sodium 35 MG [Actonel]
Risendronate Sodium Tab. 35mg, orally, once weekly
• Calcium Vitamin D combination
orally, once daily for concomitant drug

Locations
Country Name City State
Korea, Republic of Severance Hospital Seoul Seodaemun-gu

Sponsors (1)
Lead Sponsor Collaborator
Dong-A ST Co., Ltd.

Country where clinical trial is conducted

Korea, Republic of, 

Outcome
Type Measure Description Time frame Safety issue
Primary Percent change from baseline in lumbar spine bone mineral density (LS BMD) at 1 year (%) Percent change from baseline in lumbar spine bone mineral density (LS BMD) at 1 year (%) 1 year
See also
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Terminated NCT00529373 - A Study of MK-0822 in Postmenopausal Women With Osteoporosis to Assess Fracture Risk (MK-0822-018) Phase 3
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Completed NCT00541658 - A Study of a 35 mg Delayed Release Formulation of Risedronate for Osteoporosis Phase 3
Completed NCT00395395 - Effects of Water and Food Intake on the Pharmacokinetics and Pharmacodynamics of Oral Salmon Calcitonin in Healthy Postmenopausal Women Phase 1
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Active, not recruiting NCT03720886 - G56W1 in Women With Postmenopausal Osteoporosis Phase 1/Phase 2
Completed NCT01668589 - Observational Study of Denosumab (Prolia®) in Postmenopausal Women With Osteoporosis N/A
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Not yet recruiting NCT04719481 - Pravastatin Reduces Acute Phase Response of Zoledronic Acid Phase 4